(navigation image)
Home American Libraries | Canadian Libraries | Universal Library | Community Texts | Project Gutenberg | Children's Library | Biodiversity Heritage Library | Additional Collections
Search: Advanced Search
Anonymous User (login or join us)
Upload
See other formats

Full text of "Text and summary of H.R. 10358, the "Food safety and nutrition amendments of 1978"

^H,l*\%/H:h 7^/ 



// 



^% 



9oth Congress 1 
2d Session J 



COMMITTEE PRINT 



Committee 
Pkint 0.V47 



TEXT AND SUMMARY OF H.R. 10358 

THE "FOOD SAFETY AND NUTKITION AMENDIVIENTS 

OF 1978" 



PREPARED BY THE STAFF 

FOR THE USE OF THE 

COMMITTEE ON INTERSTATE AND 

FOREIGN COMMERCE 
U.S. HOUSE OF REPRESENTATIVES 

A^^D ITS 

SUBCOMMITTEE ON 
HEALTH AND THE ENVIRONMENT 




MARCH 197^\' <^. 






U.S. GOVERNMENT PRINlf 



20-9M 







WASHINGTON : 1978 






•>»>'/'/ 



COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE 
HARLEY O. STAGGERS, West Virginia, Chairman 



JOHN E. MOSS, California 
JOHN D. DINGELL, Michigan 
PAUL G. ROGERS, Florida 
LIONEL VAN DEERLIN, California 
FRED B. ROONEY, Pennsylvania 
JOHN M. MURPHY, New York 
DAVID E. SATTERFIELD III, Virginia 
BOB ECKHARDT, Texas 
RICHARDSON PREYER, North Carolina 
CHARLES J. CARNEY, Ohio 
RALPH H. METCALFE, Illinois 

JAAfES H. SCHEUER, New York 
RICHARD L. OTTINGER, New York 

HENRY A. WAXMAN, California 

ROBERT (BOB) KRUEGER, Texas 

TIMOTHY E. WIRTH, Colorado 

PHILIP R. SHARP, Indiana 

JAMES J. FLO RIO, New Jersey 

ANTHONY TOBY MOFFETT, Connecticut 

JIM SANTINI, Nevada 

ANDREW MAG - IRE, New Jersey 

MARTY RUSSO, lUinois 

EDWARD J. MARKEY, Massachusetts 

THOMAS A. LUKEN, Ohio 

DOUG WALGREN, Pennsylvania 

BOB GAMMAGE. Texas 

ALBERT GORE, Jr., Tennessee 

BARBARA A. MIKULSKI, Maryland 



SAMUEL L. DEVINE, Ohio 
JAMES T. BROYHILL, North Carolina 
TIM LEE CARTER, Kentucky 
CLARENCE J. BROWTST, Ohio 
JOE SKUBITZ, Kansas 
JAMES M. COLLINS, Texas 
LOUIS FREY, Jr., Florida 
NORMAN F. LENT, New York 
EDWARD R. ^LiDIGAN, Illinois 
CARLOS J. MOORHEAD, CaUfornia 
MATTHEW J. RINALDO, New Jersey 
W. HENSON MOORE, Louisiana 
DAVE STOCKMAN, Michigan 
MARC L. MARKS, Pennsylvania 



W. E. Williamson, Chief Clerk and Staff Director 
Kenneth J. Painter, First Assistant Clerk 
Eleanor A. Dinkins, Assistant Clerk 
WILLU.M L. Burns, Printing Editor 



Professional Staff 



Elizabeth Harrison 
Jeffrey H. Schwartz 
Brian R. Moir 
Karen F. Nelson 
Ross D. Am 



Christopher E. Dunne 
William M. Kitzmillee 
Mark J. Raabe 
Thomas M. Ryan 
James S. Cowen 



H. Thomas Greene, Associate Minority Counsel 



Subcommittee on Health and the Envikonment 

PAUL G. ROGERS, Florida, Chairman 



TIM LEE CARTER, Kentucky 
JAMES T. BROYHILL, North Carolina 
EDWARD R. AL\.DIGAN, Illinois 
JOE SKUBITZ, Kansas 
SAMUEL L. DEVINE, Ohio (Ex Officio) 



DAVID E. SATTERFIELD III, Virginia 
RICHARDSON PREYER, North Carolina 
JAMES H. SCHEUER, New York 
HENRY A. WAX\LS.N, CaUfornia 
JAMES J. FLO RIO, New Jersey 
ANDREW MAGUIRE, New Jersey 
EDWARD J. MARKEY, Massachusetts 
RICHARD L. OTTINGER, New York 
DOUG WALGREN, Pennsylvania 
HARLEY O. STAGGERS, West Virginia 
(Ex Officio) 

Stepil^n E. Lawton, Counsel 
Robert W. Maker, Director of Research and Planning 
Jo Anne Glisson, Senior Staff Associate 
Donald W. Dalrymple, Assistant Counsel 
Stephen J. Connolly, Senior Staff Associate 
Burke Zimmerman, Research Associate 
Robert M. Crano, Seiiior Staff Associate 
WiLUAM V. CoRR, Assistant Counsel 
Frances de Peyster, Minority Staff Associate 

(II) 



Oaxn CONGRESS W W W^ •« AV *^ F* r> 

:sxs..o. fj^ j^^ 10358 



IN THE HOUSE OF KEPEE8ENTATIVES 

DECKMr.En 15, 1977 

Mr. Rogers (for himself nnd ^Ir. C.\nTi:n) introclucod the fol]o^villg hill ; Avhich 
•was referred to the Coiiuuittce on Interntate and Foreiprn ro)nmerce 



BILL 

To amend the Federal Food, Drug, and Cosmetic Act to revise 
and strengthen the authority of the Secretary of Health, 
Education, and Welfare under that Act with respect to the 
distribution and labeling of food, and for other purposes. 

1 Be it enacted by the Senate and House of Beprescnta- 

2 lives of the United States of America in Congress assembled'^ 

3 SHORT TITLE; REFERENCE TO ACT; AND TABLE OF 

4 CONTENTS 

5 Section 1. (a) This Act may be cited as the ''Food 

6 Safety and Nutrition Amendments of 1978". 

7 (b) Vfhenever in this Act an amendm^ent is expressed in 

8 terms of an amendment to a section or other provision, the 

I 

(1) 



2 

1 reference shall be considered to be made to a section or otKer 

2 provision of tbe Federal Food, Drug, and Cosmetic Act. 

TABLE OF CONTENTS 

Sec. 1. Short title ; reference to Act ; and table of contents.. 
Sec- 2. Notification. 
Sec. 3. Food coding. 
Sec. 4. Food distribution records. 
Sec. 5. Kegistration of f ood processoi-s. 
Sec. 6. Preemption. 
Sec. 7. Administrative detention. 
Sec. 8. Inspections and confidentiality. 

• Sec. 9. Nutrition information and other labeling requirements. • 
Sec. 10. Import notice. 
Sec. 11. Presumption. 
Sec. 12. Definitions. 
Sec. 13. Margarine. 
Sec. 1-i. Alcoholic beverages. 

3 NOTIFICATION 

4 Sec. 2. (a) Chapter IV is amended by adding after sec- 

5 tion 41 1 the following new section : 

'6. "NOTIFICATION 

'7 ''Sec, 412. (a) Whenever a food processor — 

8 " ( 1 ) acquires information indicating that any- food 

9 which he has processed and which has left his control 
10. may he adulterated (within the meaning of section 

11 402(a) or 402(c)), he shall immediately notify the- 

12 Secretary, in such form and manner as may be prescribed 

13 by the Secretary, of such information; or 

14 "(2) institutes a recall of food which he has 

15 processed and which has left an establishment subject to 

16 his control and institutes such recall because he has reason 
1'^ . to believe the food may be adulterated or misbranded, he 



3 

1 shall immediately notify the Secretary, in such form and 

2 manner as may be prescribed by the Secretary, of such 

3 recall. 

4 ''(b) Information contained exclusively in a notification 

5 filed by any person with the Secretary pursuant to subsect'on 

6 (a) may not be introduced as evidence in any proc^edinf^ 

7 against such person under section 303 for a violation of 

8 section 301.". 

9 (b) Section 301 is amended l)y adding after paragraph 

10 (r) the following new paragraph : 

11 "(s) The faihirc to make any 'notification required by 

12 section 412.". 

13 FOOD CODING 

14 Sec. 3. (a) Chapter IV is amended by adding after 

15 section 412 (added by section 2 (a) of tliis Act) th^ follow- 

16 ing new section : 

17 ''food coding system 

18 "Sec. 413. (a) (1) Except as provided in paragraph 

19 (2), each food processor of food shall in accordance with 

20 regulations promulgated under subsection (c) — 

21 '' {^) establish and implement a food coding system 

22 to effect and monitor recalls of such food, and 

23 " (^) notify the Secretary of the establlshmcnf of 

24 such system ond of any sul)stantive revisions in it. 

25 *'(2) (A) The requirements of paragraph (1) do not 



4 

1 ^PP^y to ^ ^00^ processor to the extent that such food proces- 

2 sor processes agricultural coininodlties ^vhich are sold at re- 

3 tail ill a raw, uupceled form. 

4 ^' (B) The Secretary may h}^ regulation exempt any 

5 food processor or class of food processors from the require- 
G ments of paragraph (1) if the Secretaiy determines that 

7 comparable recpiirements are applicable to such processor or 

8 class mider a Federal law other than this Act. 

9 "(3) If the Secretary determines that a food coding 

10 system identified in a notice submitted in accordance w^ith 

11 this subsection is inadequate to eiTect and monitor a recall 

12 of the food with respect to which the system was estab- 

13 lished, the Secretaiy shall notify the food processor wlio 

14 submitted such notice of such determination, provide him 

15 with a written statement of tlie reasons for such determl- 

16 nation, provide, upon request, technical assistance to revise 

17 such system to make it adequate to effect and monitor a 

18 recall of such food, and prescribe the time witliin vrhich 
.19 such food processor shall submit a notice of the revised 

20 system. 

21 *'(b) (1) Except as provided under paragraph (2), 

22 a food coding system required to be established ])y subsec- 

23 tion (a) (1) (A) shall consist cf symbols (designated by 

24 the person establishing the sy.^tem) to identify ilie following 

25 information : 



5 

1 ''(A) The imme of tlie iiiaiiiifactiiror and, if tlifler- 

2 cut, the packer of the food coiitahied in the packa<;e.s 

3 or other containers to he marked with such synihols. 
1- ''(B) The facihty at whicli such food was manu- 
5 factured or packed if such food is manufactured or 
G packed at more than one faciUty. 

7 ''(C) The name of the food. 

8 "(D) The lot or hatch mimher, if any, of the food. 

9 " {^) The date on which the food was packed. 

10 *^(2) The Secretary may, hy reguhiilon, authorize a 

11 food coding- system for a particuhir food or class of food not 

12 to include a symhol for one or more of the items of infor- 

13 mation otho'wise required to 1)e Identified hy such sj-^stem 

14 under paragraph (1) If the Secretary determines that he- 
35 cause of the nature oi such food oi class, the volume of such 

16 food whicn is sold, or any other factor, the identification of 

17 such information is not necessary to effect or monitor a re- 

18 call of such food or class of food. 

19 ''(c) (1) The Secretary shall promulgate regulations — 

20 ''(A) to define the food processors or classes of 

21 food processors suhject to the requirements of suhsection 

22 (a), 

23 "(B) prcscrlhing the form of the notice required to 

24 he submitted under suhsection (a) (1) (B) and the food 
2o coding information to he Included In such notice, 



1 '^(C) prescribing the packages or oflier container.'^ 

2 which are to be marked with the symbols of food coding 

3 S3^stems estabhshed under subsection (a) (1) (A) and 

4 the manner in wliich siicli package^ or othej' containers 

5 are to be so marked, and 

6 ^' (D) prescribing such other matters as may be re- 

7 quired for the impk^nentation of the requirements of 

8 this section. 

9 Such regulations shall provide that if information rec^uired 
10 to be identified by any symbol of a food coding system is 
3^1 otherwise on a package or other coutainer, such package or 
3[2 other contaiacr shall not be reqaired to be marked uith sach 

13 symbol. 

14 "(2) Eegulations first promulgated under paragraph 
•15 (1) shall take elTect as prescribed by the Secretary but 
16" not sooner than one hundred and eiglit} days after the date 

17 of such promulgation. AVithin ninety days of the eflective 

18 date of the first regulations promulgated under paragraph 

19 (1), each food processor v>ho is engaged in the processing 

20 of food shall, as required by such regulations, submit the 

21 notice required by subsection (n) (1) (B) . Such regula- 

22 tions shall apply with respect to packages or other con- 

23 tainers in which food is packed after one liundred and eighty 

24 days after such effect ive date.". 

25 (b) (1) Section 403 is amended by adding after para- 

26 graph (n) tbe following new paragraph: 



7 

1 ''(o) If ill a i)ackage or other coiitiiincr, unless the 

2 package or other container is marked in accordance with. 

3 section 413.". 

4 (2) Section 301 is amended hy adding after para- 

5 graph (s) (added ))y section 2(b) of this Act) tlie fol- 

6 lowing new paragraph : 

7 '' (t) The failure to submit a notice in accordance with 

8 section 413 or the failure to revise a food coding system ia 

9 accordance with the requirements of that section. '\ 

10 FOOD DISTEIBUTIOX EECOEDS 

11 Sec. 4. (a) Chapter IV is amended by adding after 

12 section 413 (added by section 3(a) of this Act) the fol- 

13 lowing new section : 

14 ''rOOD DISTEIBUTIOX EECOEDS 

15 ''Sec. 414. (a) Except as provided in subsection (b), 
IG each food processor shall — 

17 ''(1) make and retain such records respecting the 

18' distribution of food through any establishment owned or 

19 operated by such processor for the processing of food as 

20 may "be necessary to effect and monitor recalls of such 

21 food, and 

22 " (2) make such records available to the Secretary 

23 (or to a duh^ authorized representative of the Secretary) 

24 for examination and copying on or off the premises of 

25 such processor. 



20-954— 7S- 



s 

1 "(b) The Secretary may ]»y regulation exempt any 

2 food processor or class of food processors from the rcqulre- 
o mcnts of subsection (a) if the Secretary determines that the 
4- application of such requirem.euts to such ]rrncessor or class is 

5 not necessary to effect and monitor recalls of food. 

6 ''(c) The Secretary shall promulgate re,!Z-'.lations pre- 

7 scribing the records required to be niade and retained mder 

8 subsection (a) , the form and nianner in which such records 

9 shall be made and retained, aud such other requirements as 

10 may be necessary for the implementation of such su1)section. 

11 Such regulations shall take effect on such date as the Secre- 

12 tary prescribes but not sooner tlian. one hundred and eighty 

13 days after the dale of their })ron.iu]gation, and they shall 
1-i appty with respect to dis{ribut((>i>< of food made after their 
15 efTective date.". 

1^ (b) Section 301(c) is amended (1) by striking out 

1'^ ''section 703" and inserting in lieu thereof •'"'section 413 or 

18 703", and (2) by striking out '"'section 505" and inserting 

10 in lieu thereof "section 413, 505". 

20 EEGLSTRATIOX OF FOOD PROCESSORS 

21 Sec. 5. (a) Chapter IV is amended by adding after 

22 section 413 (added by section 4(o)) the loliowiug new 

23 section : 



9 

1 "registeatiox of food rrvOCEssoKS 

2 "Sec. 415. (a) (1) Eaeli food procc>^or (Incliulin^^ 

3 each food processor located oulsidc the Fnlted States ^vllo 
4. processes food for export to tlic United States) -liall register 

5 with the Secretary — 

6 ''l-^) such person's name, 

7 " (B) such person's principal -placet of husincss, 

8 '' {^) f^'^e location of each estahlishnient owned or 

9 operated hy the processor and in v/hicli food is processed, 

10 " (^) tiie foods or (if authorized hy the Secretary) 

11 classes of foods processed in each such estahlishnient, 

12 ''(E) a description of iae categories of processing 

13 activities conducted in each such estaWishment, and 

14 '* (E) if the processing activities are not continuous, 

15 the periods of time during which such activities are 
1^ conducted. 

1'7 ''(2) Before first engaging in the processing of food a 

IS person shall register with the Secretary the information 

19 required by paragraph ( 1 ) . 

20 "(3) Any person who has registered vath the Secre- 

21 tary pursuant to paragraph (1) or (2) and who discon- 

22 tinues (on other than a temporary basis) a food processing 

23 activity identified in such registration or otherwise makes a 



10 

jL substantive change in siicli activity or in a food or establish- 

o ment associated with it shall promptly notify the Secretary of 

o such chancre. 

^ ''(b) The Secretary shall promulgate regulations pre- 

r^ scribing the form of the registration and notice required b}" 

Q subsection (a) , the manner and time in which such regis- 

rj tration and notice shall be made, and such other matters as 

g may be required for the implementation of this section. Such 

f) regulations shall take effect as prescribed by the Secretary 

jQ but not sooner than one hundred and eighty days after the 

2x date of their promulgation. 

^2 ^' (c) The Secretary may, by regulation, exempt any 

;13 food processor from the requirements of subsection (a) if 

14: the Secretaiy deteimmes that the application of such require- 

15 ments to such processor is not necessary for the protection 

16 of the public health". 

17 (b) (1) Section 403 is amended by adding after para- 

18 graph (o) (added b}' section 3 (b) ) the following new 

19 paragraph : 

20 " (p) If it was processed in an establishment not regis- 

21 tered in accordance with section 415 or if it was not dc- 

22 scribed in a registration required by such section.''. 

23 (2) Section 301 is amended by adding after paragraph 

24 (t) (added by section 3 (b) ) the following new paragraph: 



11 

% ''(u) The failure to register in accordance ^vitll section 

2 415 or the faihire to provide a notice required ])y such sec- 

? tion.". 

4 (3) Section 801 is amended hy adding at tlie end the 

5 f ollowmg : 

6 ''(e). The Secretary of the Treasury shall refuse adniis- 

7 sion of any food processed in an establishment not registered 
S in accordance with section 415.". 

9 PREEMPTION 

10 Sec. 6. Chapter I\ is amended hy adding after section 

11 415 (added hy section 4 of this Act) the following new 

12 section: 

13 ''state and local food labeling EEQI3IEEMEXTS 

•^^ "Sec. 416. (a) Except as provided in subsection (b) , 

^^ i\%. State or political subdivision of a State may establish cr 

-^^ continue in effect a labeling requirement applicable to any 

^'^ food w^hich is different from or in addition to any labeling 

^^ requirement applicable to such food under section 403. 

19 " (b) Upon' application of a State or a political sub- 

20 division thereof, the Secretary may, by regulation after no- 

21 tice and opportunity for an oral hearing, exempt from 

22 subsection (a) , under such conditions as may be prescribed 

23 in such regulation, a labeling requirement of such State or 

24 political subdivision if the Secretary determines that the 



12 

1 lequireraent is reciuired b}' comj)elling local conditions and 

2 compliance willi it would not cause a food to be in violation 

3 of a requirement under section 403.". 

4 ABMlXIfeTRATlVE DETENTION 

5 Sec. 7. (a) Section 304 is amended by adding at the 
G end the following new subsection : 

7 ''(h) (1) If during an inspection conducted under sec- 

8 tion 704 of a facility or a vehicle, a food which the officer or 

9 employee making the inspection has reason to believe is 

10 adulterated or misbranded is found in such facility or vehicle, 

11 such officer or employee may order the food detained (in 

12 accordance with regulations prescribed by the Secretary) for 

13 a reasonable period which may not exceed twenty days un- 

14 less the Secretary determines that a period of detention great- 

15 er than tv;enty days is required to institute an action under 
1() subsection (a) or section 302, in which case he may author- 

17 ize a detention period of not to exceed thirty days. Eegula- 

18 tions of tlie Secretary prescribed under this paragraph shall 

19 require that before food may be ordered detained under this 

20 paragi-aph the Secretary or an officer or employee designated 

21 by the Secretary approve such order. A detention order 

22 under this paragraph ma}' require the labeling or marking of 

23 food during the period of its detention for thei purpose of 

24 identifying the food as detained. Any person who would be 

25 entitled to claim food if it was seized under subsection (a) 



13 

1 may appeal to the Secretary a detention of such food under 

2 this paragraph. Within five days of the date an appeal of a 

3 detention is filed with the Secretary (or within such other 

4 l)criod as may be mutually agreed upon by the Secretary and 

5 the person bringing the appeal) , the Secretary shall after 
G affording opportunity for an informal hearing by order con- 

7 firm or revoke the detention. 

8 "(2) (A) Except as authorized ])y subparagraph (B), 

9 food j^ubject to a detention order issued under paragraph 
10 (1) shall not be moved by any person from the place at 
11. which it is ordered detained until — 

12 '' (i) released by the Secretary, or 

13 ■'' (ii) t]:ie expiration of the detention period appli- 

14 cable to such order, 

15 whichever occurs first. 

16 ^' (B) Food subject to a detention order under para- 
•1"^ graph (1) may be moved in accordance with regulations 

18 prescribed by the Secretary.". 

19 (b) Section 301 is amended b}' adding after paragraph 

20 (u) (added ])y section -1(1)) (2) ) the following new para- 

21 graph : 

22 *' (v) The movement of food in violation of an order 

23 under section 304 (h) or the reinovcil or alteration of any 

24 mark or label required by the order to identify the food 

25 as detained,". 



14 

% IXSPECTIOXS AXD COXFIDEXTIALITY 

2 Sec. 8. (a) Section TO-i:(a) is amended by adding^ 

3 at the end the follovang: ''An officer or employee making- 

4 an inspection under this subsection for purposes of enforcing 

5 the requirements of this Act applicable to food shall be 
G permitted, at all reasonable times to have access to and to 

7 copy and verify any records bearing on ^vhether food manu- 

8 factured, processed, packed, or held in the facility inspected 

9 is adulterated or misbranded.". 

10 (b) Section 708 is amended by adding at the end the 

11 following: ''The Secretary shall establish procedures to as- 

12 sure the confidentiality of records which are made available 

13 for inspection under section 704 and which relate to infor- 
1--^ mation which is exempt from disclosure pursuant to sub- 
15 section (a) of section 552 of title 5, United States Code, 
1^ by reason of subsection (b) (4) of such section.". 

1-^ KUTRITIOX IXFOrOIxVTIOX AXD OTHER LADELIXG 

18 EEQriEEMEXTS 

19 Sec. 9. (a) (1) Section 403 is amended by adding at 

20 the end the following : 

21 ''(o) (1) If a perishable or semiperishable food in 

22 package form, unless the package is labeled to show the sell 

23 date for such food. 

24 '' (2) For purposes of subparagraph (1) : 

25 "(^^) "'^c= tcni^ 'perishable or semiperishable food^ 



15 

1 means any food (otlicr than a raw agiicuUural com- 

2 modity) ^Yllic•ll the Secretary determines has a higli 

3 risk of any of the following as it ages : 

4 '' (i) Decay or deterioration. 

5 ''(ij) Significant loss of nutrl'ional value or 

6 palatability. 

7 ''(B) The term 'sell date' means the last date on 

8 ^"hich a perishable or semiperishablc food can be sold 

9 for consumption without a high jisk o'' jo!iaf>"c or 

10 significant loss of nutritional value or >aj^tab!lity if 

11 stored by the consumer after that date for the period 

12 which a consumer can reasonably be expected to store 

13 suclifood. 

14 ''(3) The Secretary shall promulgate regulations pre- 

15 scribing the manner in which packages are to be labeled 

16 under subparagraph ( 1 ) . Such regulations shall require that 

17 such labeling be done in such form and manner that the 

18 consumer may readily identify and understand the signifi- 
IP cance of the labeling without reference to any decoding in- 
20 formation. Such regulations shall take effect as prescribed 
2:1 by the Secretar}^ but not sooner than one hundred and 

22 eighty days after the date of their promulgation.". 

23 (2) The requirement of section 403 (oj of ilie Federal 

24 Pood, jDrug, and Cosmetic iVct, shall apply with respect 

25 to food which ]= packaged In the form In which It Is to be 



16 

1 sold to consumers after tlie effective date of the regulations 

2 of the Secretary of Health, Educntion, and Welfare, pvon,al- 

3 gated under such section. 

4 (^-') (1) Section 401 is amended hy striking out the 

5 fourth sentence thereof. 

6 (2) Section 403(g) is amended to read as follows: 

7 ^' (g) If it purports to he or is represented as a food for 

8 which a definiu'on and standard of identity have heen pre- 

9 scrihed hy regulations as provided hy ser-tion 401, unless 

10 (1) it conforms to such definition and standard; and (2) 

11 its lahel hears the name of the food specified in such delini- 

12 tion and standard.''. 

13 (3) (A) Sect'on 403 (i) is amended to read as follows: 
14- ^'(i) Unless "ts lahel hears — 

15 " (1) in the case of a food which is not suhject to 

16 paragraph (g) of this section, i)ie common or usual 

17 name (if any) of the food; and 

18 '' (2) ill case it is fahricated from two or more in- 

19 gredients — 

20 '' (-^) 'lie com)no)i or usual name of each such 

21 ingredient in the o)-der of its predominance, except 

22 that any ingredient which is a spice or flavoring 

23 and which is not sold as such shall he designated as 

24 spice or flavoring, as the case may he, unless the 

25 Secretary requires hy regulation that the common 



17 

1 or usual name of such spice or flavoiIii<r )>e on tlic 

2 label for the purpose of providing important health 

3 information to consumers, 

4 *'(B) a declaration of the percentage of any 

5 specified ingredient (other than a spice or flavor- 
Q ing) if the Secretary determines by regulation that 
7 such ingredient has a significant bearing on the 
3 quality, nutrition, acceptability^ or cost of such 
9 food, and 

10 "(C) any symbol required by the Secretary to 

11 signify the absence of an artificial flavor or color. 
]o To the extent that compliance with the requirements of 

13 subparagraph (2) is mipracticable or would result m decep- 

14 tion or unfair competition, the Secretary shall by regulation 

15 prescribe exemptions from such requirements.'\ 

16 . (B) The second sentence of section 403 (k) is repealed. 

17 (4) Section 403 is amended by adding after paragraph 

18 (o) (added by subsection (a) (1)) the following new para- 

19 graph: 

20 " (p) If a food for human consumption and in package 

21 form, unless its label bears such nutrition information relating 

22 to the food as the Secretary by regulation prescribes to pro- 

23 vide important health information to consumers.*\ 

24 (5) The amendments made by this subsection shall 

25 apply with respect to food which is inti'oduced or delivered 



18 

1 for introduction into interstate commerce after one year after 

2 the date of the enactment of this Act. 

3 (c) If the Secretary of Health, Education, and Welfare 

4 requires under section 403 (p) of the Federal Food, Drug, 

5 and Cosmetic Act that the label of a food bear nutrition 

6 information, the Secretar}^ shall — 

7 (1) notify the Federal Trade Commission of such 

8 requirement, and 

9 (2) recommend to the Commission which (if any) 

10 of such information should be required by the Commis- 

11 sion under the Federal Trade Commission Act to be 

12 included in the advertising of such food. 

13 The Secretary shall report annually to the Committee on 

14 Inlei state and Foreign Commerce of the United States House 

15 of K('prescritati\'cs and the Committee on Human Eesources 
IC of the Senate on any recommendation made under paragraph 

17 (2). 

18 IMPORT NOTICE 

19 Skc. 10. Section 801 is amended by adding after mh- 

20 section (c) (added by section 4 (b) (3) of this Act) the 

21 following new subsection : 

22 '^(f) (1) Tbe Secretary of the Treasury shall refuse 

23 admission of any food for which an import notice required 



19 

1 by paragraph (2) has not been liltd with the Secretary of 

12 Health, Education, und Welfare. 

3 ''(2) Any person who proposes to import food into 

4 the T,^nited States for commercial piiq^oses shall file with 

5 the Secretary of Health, Education, and Welfare an. im- 

6 port notice — 

7 " (A) identifying the food proposed to be imported, 
S the food processor of such food, and the registration, 
9 number assigned the food processor under section 415, 

10 ^'(B) containing such other information respecting 

11 such food as the Secretary may by regulation require 
•12 for the protection of the public health, and 

13 ^'(0) containing assurances satisfactory to the 

14 Secretar}^ that anv requirements prescribed under sec- 

15 tion 402 (a) (4) and applical)le to such food have beea 

16 complied with. 

17 ''(3) The Secretary shall promulgate regulations pre- 

18 scribing the form and content of the notice required by 

19 paragraph (2) and the time and manner in which, such. 

20 notice shall be submitted to the Secretary. Such regula- 

21 tions shall take efTect on such date as the Secretary shall 

22 prescribe but not sooner than one hundred and eighty days 

23 after the date of their promulgation, and they shall apply 



20 

1 with respect to tlie importation of food after their eflective 

2 date,". 

3 PRESUMrTION" 

4 Sec. ll. Section 709 is amended by inserlhig "or food" 

5 after ''a device". 

Q DEFIXITIOXS 

I Sec. 12. Section 201 is amended by adding cd the end 

8 the following : 

9 *'(z) (1) The term '<'ood processor' means ony person 
JO who owns or operate^ any establishment in which food is 

11 manufactm-ed, prepared, treated, packed, labeled, stored, or 

12 otherwise handled or through v.'hich food is imported for 

13 commercial purposes, except that the processing in an cstab- 

14 lishment of food for retail sale in such esrabli.^nnent does 

15 not make the owner or operator of such establishment a food 
IG processor for purposes of this Act. 

17 ^'(2) The term "'process' when used to de^^cribe an 

18 activity invohing food includes the manufacturing, import- 

19 ing, preparing, li-eating, labelljig, storing, and other handling 

20 of food.". 

21 MAIJGAI^IXE 

22 Sec. 13. Sections 301 (m), 402(e), and 407 are 

23 repealed. 



21 

1 ATX'OIIOTJC r.KVKRAr.ES 

2 8ec. 14. Section 2()1 (f) (1) Is nnioiKkMl to read as 
o follows: "(1) articles us(h1 (A) for food for inau or other 
-i animals, and (1^) as driulN' for man or otLer animal, includiuir 
•"> distilled spirits, Avincs, and malt beverages,". 

Summary of H.R. 10358, the Food Safety and Nutritiox 
Amendments of 1978 

1. notification 

Section 2 of the bill requires food processors to notify the Secretary 
9f Health, Education, and Welfare whenever they acquire information 
indicating that any food which they process, and which has left their 
control, may be adulterated within the meaning of section 402 (a) 
or (c) of the Federal Food, Drug and Cosmetic Act (hereinafter re- 
ferred to as ''the Act"). It also requires food processors to notify the 
Secretary of any recalls of food they have distributed if they have 
reason to believe that the food is adulterated or misbranded. It 
provides sanctions for failure to make these required notifications. 

These provisions of the bill are intended to obligate food processors 
to keep the Secretary apprised of their actions in detecting and re- 
calhng adulterated or misbranded foods. 

2. FOOD CODING 

Section 3 of the bill requires food processors to establish food coding 
systems to effect and monitor recalls of adulterated or misbranded 
foods. To the extent that food processors pack agricultural commod- 
ities sold at retail in a raw, unpeeled form, they aie exempted from 
this requirement. Section 3 also requires food processors to submit 
notices of their coding systems to the Secretary and to place codes 
of essential information on food packages or containers. It authorizes 
the Secretary, to exempt food processors from the requirements re- 
specting the establishment of food coding systems and the coding of 
information on packages and containers if he determines that the 
identification of such information is not necessary to effect or monitor 
a recall. It provides sanctions for failure to place codes on food contain- 
ers or packages, for failure to submit coding system notices to the Sec- 
retary, and for failure to revise a food coding system which the Secre- 
tary determines is inadequate to effect and monitor recalls of the food 
to which the food coding system applies. 

The food coding provisions of the bill require food processors to 
develop their own coding systems using s^Tnbols which specifically 
identify the name of the manufacturer and packer of the food, the 
facility at which the food is manufactured or packed, the name of the 
food, its lot or batch number, and the date it was packed. 



22 

3. FOOD DISTRIBUTION RECORDS 

Section 4 of the bill requires food processors to make and retain 
food distribution records and to make them available for examination 
and copying by the Secretary to enable the Secretary to effect and 
monitor recalls of adulterated and misbranded foods. It provides 
sanctions for failure to make and retain such records and to make them 
available for examination and copying by the Secretary. 

4. REGISTRATION OF FOOD PROCESSORS 

Section 5 of the bill requires domestic food processors and foreign 
food processors who export food to the United States, to register with 
the Secretary. It requires registrations to include the name of the 
registrant, his principal place of business, the location of each food 
processing establishment owned or operated by him, the foods or 
classes of foods processed in each establishment, a description of the 
categories of processing activities conducted in each establishment, 
and the periods of time when processing takes place if it is not con- 
tinuous. It requires the updating of registrations as changes occur 
respecting the information required to be provided. It authorizes the 
Secretary to exempt a food processor from the registration require- 
ments if he determines that the application of these requirements to 
the processor is not necessary for the protection of the public health. 
It provides sanctions for failure to register. 

In 1972 the General Accounting Office estimated there were 
approximately 80,000 food processing establishments in the United 
States. Although no figures were available as to the total number 
of foreign food processors who export food into the United States, 
a Food and Drug Administration study in 1972 estimated that the 
United States imported food from 150 countries and that 80 percent 
of these imports originated in 26 countries. In view of the vast number 
of food processors and different types of food processing operations, it 
is extremely difficult for the Secretary to have timely access to current 
information on the identity and location of food processors, the classes 
of food processed by each processor, and the types of processing 
utilized by each processor. 

5. PREEMPTION OF LABELING REQUIREMENTS 

Section 6 of the bill provides for preemption of State and local 
food labeling requirements which are different from, or in addition 
to, food labeling requirements under the Act. It provides that the 
Secretary may, by regulation and after notice and opportunity for an 
oral hearing, exempt a State or local labeling requirement from being 
preempted by a Federal requirement if he determines that it is required 
by compelling local conditions and compliance with it will not cause 
the food to be in violation of the food labeling requirements under 
the act. 

6. ADMINISTRATIVE DETENTION 

Section 7 of the bill authorizes the detention of a food by the 
Secretary for a period not to exceed 20 days if the Secretary has reason 
to believe that it is adulterated or misbranded. If the Secretary deter- 



23 

mines that a longer period of time is necessary to institute a seizure 
action against a food, the Secretary may extend the detention period 
for that food for not more than 10 days. The biJl also provides j)ro- 
cedures for appeals and informal hearings respecting detentions of 
food. It provides sanctions for the unauthorized movement of food in 
violation of a detention order and for the removal or alteration of 
any mark or label required by a detention order to identify the detained 
food. 

7. INSPECTIONS AND CONFIDENTIALITY 

Section 8 of the bill requires the owner, operator, or agent in charge 
of a food processing facility to permit access to such facility by an 
officer or emplo3^ee of the Department of Health, Education, and 
Welfare to copy and verify records bearing upon whether food manu- 
factured, processed, packed, or held in the facility is adulterated or 
misbranded. It also requires the Secretary to establish procedures to 
assure the confidentiality of records which are made available for 
inspection and which are trade secrets exempted from disclosure under 
the Freedom of Information Act. It provides sanctions for refusal to 
permit entry or inspection in a facility for copying or verification of 
records bearing upon adulteration or misbranding. 

8. NUTRITIONAL INFORMATION AND OTHER LABELING REQUIREMENTS 

Section 9 of the bill provides for changes in the labeling require- 
ments for foods under the Act as follows: 

a. Perishability Labeling 

Section 9(a) requires '^sell-date" labeling for perishable and semi- 
perishable foods in packaged form. It defines a ''perishable or semi- 
perishable food" as a food, other than a raw agricultural commodity, 
which the Secretar}^ determines which, as it ages, has a high risk of 
decay, deterioration, or significant loss of nutritional value ^or palat- 
ability. *'Sell-date" is defined as the last date on which a perishable 
or semiperishable food can be sold for consumption without a high 
risk of spoilage or significant loss of nutritional value or palatability 
if stored by the consumer after that date for the period which the 
consumer would reasonably be expected to store the food. 

Existing law provides the Secretary implicit authority to require sell- 
date and food storage information on food labels in cases where the lack 
of this information may result in a food being adulterated or rnis- 
branded. Since the extent of this authority (and the manner in which 
this authority is to be exercised) is unclear imder the Act, the bill 
proposes explicit statutory authority to facilitate the development 
of food perishability labeling requirements. 

6. Ingredient Labeling 

Section 9 also requires the so-called mandatory ingredients in foods 
subject to a standard of identity to be listed on the label. It requires 
the listing of each coloring on the label of foods containing added 
artificial or natural colorings. It provides that individual spices and 
flavorings need not be specifically listed on the label unless the Secre- 
tary issues regulations to require their listing for the purpose of 
providing important health information to consumers. It authorizes 



24 

the Secretary to require the use of a symbol on the label of a food to 
signify the absence of any artificial flavor or color. In addition, it 
authorizes the Secretary to require a declaration of the percentage of 
any specified ingredient (except a spice or flavor) on the label of a 
food, if he determines by regulation that the ingredient has a signifi- 
cant bearing on the quality, nutrition, acceptability, or cost of the 
food. Finally, it requires the listing of all food ingredients in the 
descending order of their predominance. 

c. Nutritional Labeling Information 

Section 9 further authorizes the Secretary to require the labels of 
packaged foods to bear nutritional information with respect to the 
food in order to provide health information to consumers. If these 
foods fail to bear this required nutritional information they would be 
deemed to be misbranded and subject to the enforcement provisions 
of the Act. 

Under existing law, the Secretar}^ may only require full nutritional 
information on the labels of special dietary foods, fortified and en- 
riched foods, and foods for which nutritional claims are made by the 
processor or distributor. Nutritional labeling for other foods is 
voluntary. 

d. Nutritional Information in Advertising 

Finally, section 9 requires the Secretary to notify the Federal 
Trade Commission of requirements for nutritional information in 
food labeling under section 403 (p) of the Act and to recommend to the 
Commission which, if any, of this nutritional information should be 
required by the Commission to be included in food advertising. It 
requires the Secretary to report annually to the appropriate commit- 
tees of the House and Senate on any recommendations he makes to 
the Commission respecting the inclusion of nutritional information in 
food advertising. 

This provision is intended to foster interagency coordination of 
regulatory requirements respecting nutritional claims in food labeling, 
and advertising, and to help eliminate inconsistencies in these require- 
ments which could mislead or confuse consumers. 

9. IMPORT NOTICES 

Section 10 of this bill requires persons who import food into the 
United States to file ''import notices" identifying the imported food 
and its processor and containing other information which the Secretary 
may require for the protection of the public health. An import notice 
would also be required to contain assurances that good manufacturing 
l)ractice regulations, applicable to a food, have been complied with 
by the foreign processor. The bill provides sanctions for failure to file 
these import notices and requires the Secretary of the Treasury to 
refuse admission into the United States of any food for which an 
import notice has not been filed. 

10. PRESUMPTION RESPECTING FOOD AND INTERSTATE COMMERCE 

Section 11 of the bill provides a rebuttable presumption that the 
connection with interstate commerce, required for Federal jurisdiction, 
exists with respect to a food in any action to enforce the requirements 
of the food i)rovisions of the Act. 



25 

Presently, food inspectors must collect documentation of the inter- 
state shipment of a food before the Secretary can bring a seizure action 
against it. Experience has shown that virtually all food is in interstate 
commerce under applicable judicial interpretations. Thus, the existing 
legal requirements merely serve to cause unnecessary delay and im- 
pede agency actions against adulterated and misbranded foods. 

11. DEFINITIONS 

Section 12 defines ''food processor" to mean any person who owns 
or operates any establishment in which food is manufactured, prepared, 
treated, packed, labeled, stored, or otherwise handled or through which 
food is imported for commercial purposes. This definition also provides 
that the processing in an establishment of food for retail sale in that 
establishment does not make the owner or operator of that establish- 
ment a food processor for purposes of the Act. Section 1 2 also defines 
the term ''process," when used to describe an activity involving food, 
as including the manufacturing, importing, preparing, testing, label- 
ing, storing, and other handling of food. 

12. MARGARINE 

Section 13 of the bill repeals the provisions of the Federal Food, 
Drug, and Cosmetic Act pertaining to adulterated margarine and to 
the sale and offering for sale of margarine not meeting special require- 
ments under the Act. 

13. ALCOHOLIC BEVERAGES 

Section 14 of the bill amends the definition of "food" under the 
Federal Food, Drug, and Cosmetic Act to specifically include distilled 
spirits, wines, and malt beverages. 

O 



UNIVERSITY OF FLORIDA 

■lllllillllil 

3 1262 09119 2459